Evaluations of cannabidiol as a novel food are suspended pending new data

EFSA scientists are unable to assess the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties surrounding potential hazards related to the recording of CBD currently undetectable.

Cannabidiol is a substance made from Cannabis sativa L.-plants and can also be synthesized chemically. The European Commission considers that CBD can be classified as a novel food if it meets the conditions of the EU novel food legislation. Following numerous requests for CBD under the Novel Food Regulation, the Commission asked EFSA for an opinion on the safety of human consumption of CBD.

Data gaps and uncertainties

EFSA panel of experts on nutritionNovel Foods and Food Allergens (NDA Panel) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA panel, Professor Dominique Turck, stated: “We have identified a number of dangers associated with CBD intake and have determined that the many data gaps on these health effects need to be filled before these assessments can be completed. continue. It is important to note that we have not concluded that CBD is unsafe as a food.”

There is insufficient data on the effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, and psychological well-being of people.

Animal studies show significant adverse effects, particularly in relation to reproduction. It is important to determine whether these effects are also seen in humans.

applicant support

Ana Afonso, Head of the EFSA Nutrition and Food Innovation Unit, said: “When information is missing, it is not uncommon for evaluations of novel foods to be suspended. It is the applicant’s responsibility to fill in the data gaps. We are working with them to explain how the additional information can be provided so that the uncertainties are resolved.”

As part of the follow-up, EFSA is organizing an information session for applicants and other groups or individuals interested in this topic and novel foods in general. The online event will take place on April 28.

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